This article provides a summary of the background and development of the dual ISO-IEC 14971:2000, Medical Devices - Risk management - Application of risk management to medical devices. The standard, which was developed by a joint ISO/TC 210-IEC/SC62 committee, was issued in December 2000 as the world standard on risk management for medical devices. That it was unanimously approved for publication as an international standard by four bodies, ISO, IEC, CEN and CENELEC, speaks highly for the effectiveness of the joint development process. International regulatory bodies around the world are currently at various stages of implementing the standard.
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